Healthy Environments Study (HEROs)

Sponsor

Colorado State University (Other)

Overall Status

Completed

CT.gov ID

NCT04743531

Collaborator

University of Colorado, Denver (Other), New Mexico State University (Other), Pennington Biomedical Research Center (Other), Cornell University (Other)

Enrollment

Locations

Arms

Actual Duration (Months)

17.5

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Obesity is a multi-dimensional problem that has roots in infancy and tracks into adulthood. Obesity is represented disproportionately among children and families from low socioeconomic and minority backgrounds, particularly in rural areas that have limited access to food, activity, and health-related services. There is a need for culturally-tailored, effective interventions that can positively impact the environments (home, preschool, community) in which young children grow and develop their eating and activity behaviors. Developing family interventions, particularly for families with limited resources, requires improving caregivers' health literacy and home food/activity environments, and also requires tailoring to accommodate the realities of stressful and unpredictable family settings. The overall objective of this proposed HEROs Study (HEalthy EnviROnments Study) is to develop a companion, technology-based, interactive family intervention that will promote healthy lifestyles for young children in both Head Start and family settings.

Condition or Disease	Intervention/Treatment	Phase
Health Behavior Childhood Obesity	Behavioral: HEROs	N/A

Detailed Description

This intervention study will test the impact of the intervention through a quasi-experimental staggered implementation pilot design. The aims will test whether the implementation of a parent-child interaction intervention, focusing on eating and activity behaviors, will improve children's eating behaviors, motor performance and parent-child interactions in these domains. This project seeks to answer the following research questions:

Do children participating in the family-based intervention demonstrate enhanced PA and eating behaviors?

Hypothesis 1.1: Children receiving the family-based intervention will have higher PA levels and enhanced motor skills compared to children in the control group.
Hypothesis 1.2: Children receiving the family-based intervention will demonstrate enhanced eating behaviors compared to children in the control group.

Can the home environment be improved by parents' self-monitoring of food availability and electronic devices; and the application of mindful parenting strategies?

Hypothesis 2.1: Evaluation of food items in the home and electronic devices in the child's bedroom will demonstrate a more positive home environment of participants receiving the family-based HEROs intervention.
Hypothesis 2.2: Parents will report more positive parent-child interactions after receiving the family-based HEROs intervention.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Bridging Home and Preschool Environments to Promote Healthy Eating and Activity Behaviors and Prevent Obesity in Early Childhood

Actual Study Start Date :

Sep 1, 2019

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Sep 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Families living in rural Colorado will participate in the HEROs intervention in Fall 2019.	Behavioral: HEROs Intervention Description: The intervention will consist of a 6-week family workshop series, held one evening per week for six consecutive weeks. The intervention modules will be delivered by trained researchers at two preschool sites in rural Colorado in Fall 2019 and Spring 2020. The primary caregiver and preschool child will be the targets of the study. Each of the workshops will be structured to include joint caregiver-child activities and programming that is tailored for caregivers and children individually. Caregivers will learn about and engage in activities related to healthy eating and picky eating; physical activity and motor development; and parenting strategies. Children will participate in activities focused on healthful eating and physical activity that supports content their parents are learning.
Experimental: Staggered Intervention Families in the staggered intervention arm will serve as controls for the first intervention arm during Fall 2019. Families the staggered intervention arm will then participate in the HEROs intervention in Spring 2020.	Behavioral: HEROs Intervention Description: The intervention will consist of a 6-week family workshop series, held one evening per week for six consecutive weeks. The intervention modules will be delivered by trained researchers at two preschool sites in rural Colorado in Fall 2019 and Spring 2020. The primary caregiver and preschool child will be the targets of the study. Each of the workshops will be structured to include joint caregiver-child activities and programming that is tailored for caregivers and children individually. Caregivers will learn about and engage in activities related to healthy eating and picky eating; physical activity and motor development; and parenting strategies. Children will participate in activities focused on healthful eating and physical activity that supports content their parents are learning.

Arm

Intervention/Treatment

Experimental: Intervention

Families living in rural Colorado will participate in the HEROs intervention in Fall 2019.

Behavioral: HEROs

Intervention Description: The intervention will consist of a 6-week family workshop series, held one evening per week for six consecutive weeks. The intervention modules will be delivered by trained researchers at two preschool sites in rural Colorado in Fall 2019 and Spring 2020. The primary caregiver and preschool child will be the targets of the study. Each of the workshops will be structured to include joint caregiver-child activities and programming that is tailored for caregivers and children individually. Caregivers will learn about and engage in activities related to healthy eating and picky eating; physical activity and motor development; and parenting strategies. Children will participate in activities focused on healthful eating and physical activity that supports content their parents are learning.

Experimental: Staggered Intervention

Families in the staggered intervention arm will serve as controls for the first intervention arm during Fall 2019. Families the staggered intervention arm will then participate in the HEROs intervention in Spring 2020.

Behavioral: HEROs

Outcome Measures

Primary Outcome Measures

Change in children's diet behaviors [Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)]
The Healthy Kids (HK) survey (Townsend et al 2018) examines 23 behaviors in the child's family environment to identify nutrition, activity, and child feeding factors associated with pediatric obesity in low-income populations. Survey responses will be coded using 4 response options per item (4=most healthful; 1=least healthful). Items will be summed into 6 subscales: vegetables, sweetened beverages, activity (screen and physical activity), snacking, energy density, and BMI.
Change in children's gross motor skill scores [Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)]
The Test of Gross Motor Development-2 (TGMD-2) will be used to assess child's motor skill competence. The TGMD-2 assesses 12 skills: run, gallop, hop, leap, horizontal jump, slide (locomotor skills); and striking a stationary ball, stationary dribble, kick, catch, overhand throw, and underhand roll (object control skills). A research team member will demonstrate the proficient technique to the child, then the child will be asked to perform the skill twice. Researchers will score each attempt to perform the skill based on set criteria (Logan et al 2011).
Change in children's physical activity levels [Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)]
Children's physical activity levels will be assessed using the cumulative time in sedentary and moderate and vigorous physical activity (MVPA). Data will be collected using the ActiGraph GT9X accelerometer, which participants will be asked to wear for 7 days during each data collection period (baseline, follow up at month 2, follow up at month 4). Sedentary and MVPA cut points for children will be used to measure of the mean amplitude deviation of acceleration [Vaha-Ypya 2015].
Change in children's willingness to try new foods [Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)]
Children's willingness to try new foods will be conducted using a Tasting Panel, a food preference assessment, with each child. The child will be asked to taste 8 foods in a self-selected order. This panel includes sweet and savory foods, fruits, vegetables, and protein. After tasting a food, children will be asked to place the food in front of one of 3 cartoon faces that best describes how they think the food tasted: a smiling face (yummy), a neutral face (just ok), or a frowning face (yucky). Refusals to taste a food will be recorded [Johnson et al 2019].

Secondary Outcome Measures

Change in child BMI [Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)]
Children's weight (measured on a digital scale) and height (measured using a portable stadiometer) will be used to determine a BMI using the CDC standardized growth curves.
Change in caregivers' physical activity levels [Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)]
Caregivers' physical activity levels will be assessed using the cumulative time in sedentary and moderate and vigorous physical activity. Data will be collected using the ActiGraph GT9X accelerometer, which participants will be asked to wear for 7 days during each data collection period (baseline, follow up at month 2, follow up at month 4). Sedentary and MVPA cut points for children will be used to measure of the mean amplitude deviation of acceleration [Vaha-Ypya 2015].
Change in parent-child feeding practices [Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)]
The Food Parenting Inventory (FPI) [Power et al 2019] measures food parenting practices and has been validated among diverse populations. We will utilize 5 subscales that link specifically to our HEROs curriculum including: Encourages Exploration of New Foods (3 items), Offers New Foods (3 items), Repeatedly Presents New Foods (3 items), Pressure to Eat (4 items) and Food as Reward (3 items). Response options are a 5-point Likert scale (never to always). The mean score per FPI scale will be calculated for analyses.
Change in physical activity parenting practices [Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)]
The Preschooler's Physical Activity Parenting Practices (PPAPP) instrument [O'Connor et al 2014] has been validated in a large sample of parents of preschoolers. The Engagement/Structure sub-scale (15 items), and 2 single-items (Have outdoor toys; Not enrolled in sports-reverse coded) measures parenting practices that encourage child physical activity. Practices that discourage child physical activity include 4 subscales: Promote Inactivity (3 items), Promote Screen Time (3 items), Psychological Control (5 items), and Restriction for Safety Concerns (4 items). Response options are a 5-point Likert scale (never to always). A mean score per PPAPP scale will be calculated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adults who identify as the primary caregiver of a child enrolled in a Head Start or preschool center ;
Caregivers who report their child is without disability, illness, or disorder that would significantly affect dietary or activity behaviors (e.g., diabetes, cerebral palsy);
Participants who communicate in either English or Spanish language.